{"entity":{"id":"avasopasem-manganese","kind":"drug","name":"Avasopasem manganese","aka":[],"tldr":"Avasopasem is Galera Therapeutics' radioprotector for the severe mouth ulcers of head and neck chemoradiation; its phase 3 trial met its main goal but the FDA asked for another study in 2023.","summary":"Avasopasem manganese is given by infusion before each radiotherapy fraction. The ROMAN phase 3 trial in head and neck cancer patients receiving cisplatin chemoradiation reduced the incidence of severe oral mucositis compared with placebo. The FDA issued a complete response letter in August 2023 asking for an additional trial before approval. A related compound, rucosopasem, is being tested to increase the effect of stereotactic radiotherapy on tumours rather than protect normal tissue.","status":"phase-3","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of avasopasem","url":"https://clinicaltrials.gov/search?intr=avasopasem"}],"tags":["radiation-wave3"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["radioprotectors"],"targets":[],"drugs":[],"companies":["galera-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo radiation expansion","editedOn":"2026-09-16"},"code":"GC4419","modality":"Superoxide dismutase mimetic small molecule","mechanism":"A manganese complex that mimics the enzyme superoxide dismutase, converting the superoxide radicals that radiation creates in normal tissue into hydrogen peroxide, which healthy cells clear more easily than tumour cells.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/avasopasem-manganese/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"}],"technology":[{"id":"radioprotectors","kind":"technology","name":"Radioprotectors and normal-tissue sparing drugs","route":"/technologies/radioprotectors/"}],"company":[{"id":"galera-therapeutics","kind":"company","name":"Galera Therapeutics","route":"/companies/galera-therapeutics/"}]}}